The National Institutes of Health will recognize multiple Principal Investigators (PI) on a selected set of grant programs beginning in September, 2006 (http://grants2.nih.gov/grants/multi_pi/). This notice reminds the research community that the multiple PI option will be available only for programs involved in the pilot; that all participating PIs will need to be registered on the NIH Commons prior to submission; and that Multiple PI applications must include a leadership plan. Finally, this notice describes the management strategies for Multiple PI projects that are in place for the pilot initiatives and special review criteria that will be used for these pilots. Other policies and management strategies will be announced as they are developed.

Pilot Multiple PI Programs: The following program announcements (PAs), Requests for Applications (RFAs) and Notices describe programs involved in the Multiple PI Pilot. It should be noted that Multiple PI leadership is an option only for those applicants responding to the Pilot Initiatives. Although the modified PHS 398 form accommodates multiple PIs, applications with multiple PIs that are not submitted in response to the pilot initiatives may be delayed or in some cases may not be reviewed.

NOT-AT-06-003 - Update to PAR-06-108 and RFA-AT-06-001, Developmental Centers for Research on Complementary and Alternative Medicine: Addition of the Option to Include Multiple Principal Investigators

NOT-LM-06-004 - Update to PA-06-094, NLM Research Grants in Biomedical Informatics and Bioinformatics: Addition of the Option to Include Multiple Principal Investigators

All Multiple PI projects are required to include a new section describing the leadership of the project.
(For applications submitted in paper using the PHS398 this is now section I in the PHS398 Research Plan. For applications submitted electronically using the SF424 (R&R) follow the instructions provided in the Application Guide.).
Section I. Multiple Principal Investigator Leadership Plan:
For applications designating multiple PIs, a new section entitled Leadership Plan is now included as Section I, of the research plan. The governance and organizational structure of the research project are described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program are delineated for the PIs, including responsibilities for human subjects or animal studies as appropriate. Note that single PI applications and applications that are not submitted in response to the announcements included in the Pilot are not to include a Leadership Plan. Examples of leadership plans are available on the Multiple PI website at http://grants.nih.gov/grants/multi_pi/index.htm.

Management Strategies Available for Programs in the Pilot: Three management strategies for these projects are being tested. These strategies are likely to evolve as the pilot phase of implementation informs the process.

Multiple PIs at One Institution – Informal Allocation. In this strategy, a single application is submitted, and a single award is made to the institution. The PIs and their institution may request a division of the budget either in the application or at the time of award. The request will be noted on the Notice of Grant award as a footnote. Implementation of the request is left to the Institution. Communication between the PIs and the NIH is delegated to a single contact PI, but all PIs will have access to all documents pertaining to the project via the NIH Commons. The contact PI designation may rotate among the PIs on an annual basis.

Multiple PIs at Multiple Institutions – Subcontract/Consortium Model. In this strategy, a single application is submitted, and a single award is made to the applicant institution. Note that the contact PI must be located at the applicant institution. The components of the project at the other Institutions will be supported using a traditional consortium/subcontract arrangement. The relationship between the institutional partners must be designed to support all components of the project including those at the secondary institutions. All PIs, including those at the consortial institutions, will have access to documents pertaining to the project via the NIH Commons. The contact PI designation may rotate only among those PIs who are located at the applicant/awardee Institution.

Multiple PIs at Multiple Institutions – Linked Awards Model (only available through NOT-DK-06-007 and NOT-LM-06-004 ). In this strategy, linked applications are submitted by each partnering Institution, and will be associated and reviewed as a single project. If an award is made, each of the involved institutions will receive a separate grant to fund the collaborative project. The institution with the contact PI submits a full application while other institutions submit mini-applications that include Institution-specific information but lack an Abstract and Research Plan. The mini-applications refer to the full application; all applications are linked by a common project title and by cross-references within each application. All of the applications are reviewed together as a single project. PIs and their Institutions will collaborate to produce identical annual Progress Reports, which detail progress on the project as a whole, thus enabling the project to be administered as a single project. The contact PI, which may rotate between the PIs on an annual basis, is responsible for communication with the NIH for the project as a whole. The NIH will communicate with the individual Institutions for Institution-specific issues. Please note that this option will only be available during the pilot and for special programs such as RFAs and PAs until administrative systems have been built to handle large numbers of applications and awards of this type.

A fourth management strategy,Multiple PIs at One Institution – Formal Allocation, is being considered by the NIH. This strategy would either involve multiple awards to one institution or the allocation of funds within the Notice of Grant award mandating the generation of sub-accounts within an Institution. This would provide individual budgets for different components of the project that might be managed by different PIs. The NIH is gathering input from the scientific community concerning the utility of this model, but it is not being piloted at this time.

REVIEW CRITERIA for ALL APPLICATIONS in the Multiple PI Pilot: The review criteria normally employed for NIH research grant applications have been modified slightly to accommodate both single and multiple PI applications. The revised language for multiple PI applications is indicated in bold font below:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Investigators: Are the principal investigator(s) and key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the principal investigator(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

MULTIPLE PI IMPLEMENTATION TIMELINE: The first Multiple PI awards will be issued in September, 2006. The NIH anticipates that Multiple PI leadership will be an option for most research project grant applications beginning with the February 1, 2007 application receipt date. After that, Multiple PIs are likely to be an option for other grant mechanisms as they transition to electronic submission. Note: The NIH does not anticipate using linked awards for applications received outside of the pilot program until computer systems can be developed to provide an efficient method for handling linked applications and for recognizing and reporting on linked awards. The NIH expects systems to be in place that will accommodate general use of linked applications and awards during Fiscal Year 2008. Prior to that time, linked awards will be available only when announced in advance for a specific initiative.